N/A
N=169
Restylane Perlane Lidocaine for Correction of Midface Volume Deficit and/or Midface Contour Deficiency
Midface Volume Deficit
Bottom Line
View on ClinicalTrials.gov: NCT03097783 ↗Enrolled (actual)
169
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcome: Primary: Percent Responders With 1 Point Improvement on the Medicis Midface Volume Scale — 67; 8 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Restylane Perlane Lidocaine (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Responders With 1 Point Improvement on the Medicis Midface Volume Scale |
67; 8 | — |
Summary
This is a randomized, multi-center, evaluator-blinded, no-treatment controlled study to evaluate the efficacy and safety of Restylane Perlane Lidocaine for correction of Midface Volume Deficit and/or Midface Contour Deficiency.
Eligibility Criteria
Inclusion Criteria
- Signed informed consent
- Men or women aged 18 years of age or older of Chinese origin
- Subjects willing to abstain from any other facial plastic surgical or cosmetic procedures below the level of the lower orbital rim for the duration of the study
- Subjects seeking augmentation therapy for the midface
- MMVS score of 2, 3 or 4 on each side of the face as assessed by the blinded evaluator
Exclusion Criteria
- Known/previous allergy or hypersensitivity to any injectable HA gel/local anaesthetics, e.g.lidocaine or other amide-type anaesthetics.
- Previous surgery or tattoo in the area to be treated
- Previous tissue augmentation therapy or contouring with any permanent (non-biodegradable) or semi-permanent filler, autologous fat, lifting threads or permanent implant below the level of the lower orbital rim.
- Previous use of any hyaluronic acid based or collagen based biodegradable facial tissue augmentation therapy below the level of the lower orbital rim or neurotoxin within 12 months before treatment.
- Scars or deformities, active skin disease, inflammation or related conditions, such as infection, perioral dermatitis, seborrheic eczema, rosacea, acne psoriasis and herpes zoster near or in the area to be treated.
- Other condition preventing the subject from entering the study in the Investigator's opinion.
Data sourced from ClinicalTrials.gov (NCT03097783). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.